Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
375 participants
INTERVENTIONAL
2023-11-13
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pre-meal water + Hypocaloric diet
premeal water ( 500 ml) before each main meal, three times per day + hypocaloric diet
Water intake and weight control in older adults - Premeal Water + hypocaloric diet
Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive specific instructions for daily water intake timing and volume.
Daily water + Hypocaloric diet
total daily water prescription (1500 ml/d) + hypocaloric diet
Water intake and weight control in older adults - Total Daily Water + hypocaloric diet
Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive specific instructions for total daily water intake.
Hypocaloric Diet alone
hypocaloric diet with not instructions regarding water intake
Water Intake and weight control in older adults - hypocaloric diet alone
Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive instructions in the hypocaloric diet, without specific fluid intake recommendations.
Interventions
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Water intake and weight control in older adults - Premeal Water + hypocaloric diet
Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive specific instructions for daily water intake timing and volume.
Water intake and weight control in older adults - Total Daily Water + hypocaloric diet
Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive specific instructions for total daily water intake.
Water Intake and weight control in older adults - hypocaloric diet alone
Individuals will be randomly assigned to one of three groups. All individuals will receive counseling in a structured hypocaloric meal plan (1200-1500 kcal) that is consistent with a healthy dietary pattern as described by the Dietary Guidelines for Americans. This group will receive instructions in the hypocaloric diet, without specific fluid intake recommendations.
Eligibility Criteria
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Inclusion Criteria
* BMI ≥25 kg/m2
* weight stable (+/- 2 kg) in past 6 months
* willing to provide consent and comply with study protocol
Exclusion Criteria
* uncontrolled hypertension (\>159/99 mmHg)
* medical condition requiring specialized diet prescription (eg, T2D, CHF wih fluid restriction)
* medical condition that precludes participating in a physical activity program (eg, orthopedic injury)
* current or history of GI disease (eg, Crohn's), GI surgery, or medications which impact GI function
* allergies or aversions to foods included in the test meals
50 Years
ALL
Yes
Sponsors
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Virginia Polytechnic Institute and State University
OTHER
Responsible Party
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Brenda Davy
Professor
Principal Investigators
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Brenda Davy, PhD RDN
Role: PRINCIPAL_INVESTIGATOR
Virginia Polytechnic Institute and State University
Locations
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Virginia Tech
Blacksburg, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Brenda M Davy, PhD
Role: primary
Elaina L Marinik, PhD
Role: backup
Other Identifiers
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22-624
Identifier Type: -
Identifier Source: org_study_id